By,Lavannya B Vartak

Priyanka B HartiVidyashri Motgi

Saraswati Kulkarni

Transgenic drugs

Transgenic: Having genetic material (DNA) from another species. This term can be applied to an organism that has genes from another organism. It is understood that the foreign genes are in the transgenic animal's germ-cell DNA and so can be transmitted from one generation to the next.

A drug is a substance which may have medicinal, intoxicating, performance enhancing or other effects when taken or put into a humanbody or the body of another animal and is not considered a food or exclusively a food.

Introduction

The process of genetically modifying an animal usually starts with combining certain fragments of DNA together in a laboratory, known as recombinant DNA. Then it is put into the animal which can pass on the recombinant DNA to the offspring. These animals contain an additional protein from the constructed DNA needed to create the drug.

genetically engineered mammals/animals may provide an important source of these protein drugs, because the production of recombinant proteins in the milk, blood, or eggs of transgenic animals present a much less-expensive approach to producing therapeutic proteins in animal cells.

The Basic Process of Genetic Engineering

The Basic Process of Genetic Engineering (continued)

ATryn Insulin Lactoferrin (Breast Milk Supplement) Anti-Cancer Drugs Erythopoietin

Examples of Drugs Made from Genetic Engineering of Animals

ATryn

• Goats are one of the first animals to be used in the genetic engineering process.

• Biotech Therapeutics currently owns a farm in Charlton, Massachusetts.

• 30 goats are currently being used to make the anti- blood clotting protein, Antithrombin, on this farm.

• Antithrombin is produced from the mammary glands of transgenic goats, and harvested from their milk.

• In 2009, GTC- Biotherapeutics Ovation Pharamceuticals Inc. announced that the Food and Drug Administration (FDA) had approved ATryn (Antithrombin Recombiant) for the prevention of blood clotting in Antithrombin deficient patients.

• Choosing to genetically engineer goats to produce the drug is an efficient method and useful because Antithrombin is hard to come by or is simply not available.

Lactoferrin & Insulin

Most common from genetically modified cows are lactoeferrin, breast milk produced from cows in the form of a supplement, and insulin.

Lysozome, which fights bacteria and improves infants immune system in their few days of life, can be found in genetically modified cows, which has properties of breast milk.

This figure better explains genetically engineering of Insulin

Anti-Cancer Drugs

Chickens are also being used in the process of producing pharmaceutical drugs.

A specific area found was the Roslin Institute in UK. They have started genetically modifying chickens to produce cancer drugs, which contain lifesaving, immune system proteins in their eggs for cancer patients.

This is a very cheap and efficient method of making pharmaceutical drugs. Normally this process would take a very long time. Using chickens to produce this drug makes it faster than any other method of drug manufacturing.

Chickens at Roslin Institute in UK

This particular method does not transmit the bird flu virus. Chickens are also being GM to treat lung, cervical, and breast cancer. Chickens naturally produce proteins. Genetically modifying makes the protein value increase. As said in the table, “to ensure the desired protein was only produced in the egg they linked the therapeutic protein gene with the chicken Ovalbumin Gene which is only found in the egg white part of an egg.”

Erythropoietin

Many mammals are being genetically engineered to produce Erythropoietin, like sheep or cows. EPO is used to treat anemia or given to patients after chemotherapy. “EPO is a glycoprotein (protein-sugar conjugate) that serves as the primary regulator of red blood cells (erythrocytes) in mammals” (Ritter).

Erythropoietin (Epoetin Alfa or EPO)

Recombinant DNA of EPO

“Erythropoietin [epoetin alfa (Epogen, Procrit)] is used in many installation-fitting clinic. The most common use is in people with anemia associated with abnormal function (dysfunction) kidney

Many athletes, such as cyclists and runners, use EPO because the increasing number of red blood cells can increase oxygen capacity and produce improved physical activity. Creating Erythropoietin through genetic engineering, it is much more efficient than what humans can produce alone.

Ethical concern is ever increasing as the technology grows, including the issue of lab animal welfare

These ethical issues include questions such as:• Should there be universal protocols for

transgenesis?• Should such protocols demand that only the

most promising research be permitted? Is human welfare the only consideration? What about the welfare of other life forms? Should scientists focus on in vitro (cultured in a

lab) transgenic methods rather than, or before, using live animals to alleviate animal suffering?

The ethical concerns surrounding transgenesis:

A lot of people, mainly animal-rights activists, are concerned about genetically modifying animals to create therapeutic pharmaceutical drugs.

Concerns on Genetically Modifying Animals

The idea of clones appears in the concerns in these animals because it is such a widespread controversy. Many people feel that cloning is harmful for the animals. However, unlike clones which are “supposed to be genetically identical to animals that already exist, genetically engineered animals have DNA from other organisms, often other species, inserted into their genome” (Northwestern University). Since the DNA is already made, it is safe.

Concern: Confusion between Cloning and Genetically Engineering

The goal to use animals for human needs has been a long-term goal for many scientists. Not only does it “have vast potential for patients, but also that it can be carried out without harm to the animals”

Martin Stephens, the vice president for animal research issues at the Human Society in Washington, acknowledges that the technique of this drug production does not harm the goats but still feels troubled by the development. He says that it “represents a dark cloud on the horizon in that we would rather not see more uses of animals drummed up”.

Concern: The Morals and Ethics Concerning the Welfare of the Animals

Some also have negative feelings over the animals welfare because of the fear these animals may end up just being used for breeding so the recombinant DNA is passed on to the offspring. Transgenic animal research is still subject to existing regulations governing animal research.

There is also an added concern with cows & chickens, because the fear of transference of diseases through drugs, such as mad cow disease and bird flu.

many clinical trials the animals and the drugs go through that this is not common at all. So therefore, it is safe to use.

Plus, scientists genetically engineer these animals to keep them away from producing these diseases and becoming immune, so this should not be a concern.

Concern: Transference of Diseases

difficult challenges for 21st century scientists and ethicists, and education and meaningful, respectful discourse are just the beginning of what is required to tackle such complex ethical issues.

Until we as a society or, perhaps, as a global entity can agree on what beings—human or otherwise—are worthy of moral and legal status and respect,

we can expect intense cross-disciplinary debate and discussion as new life forms are created through science and medicine.

CONCLUSION

Genetically modifying animals to produce pharmaceutical drugs will slowly become a common and efficient way to treat diseases. It also can provide drugs/treatment for a lot more patients, because animals can produce a larger amount than humans using genetic engineering.

The FDA has regulated many of the drugs produced, basing on the fact if the drug is safe and effective. They also keep in mind the ethical concerns of the community.

Jones, By Hilary. "Chicken Eggs Make Human Drugs | COSMOS Magazine." COSMOS Magazine | The Science of Everything. Web. 07 Nov. 2011. <http://www.cosmosmagazine.com/news/966/chicken-eggs-make-human-drugs>.

Lavine, G. (2009). FDA approves first biological product derived from transgenic animal. American Journal Of Health-System Pharmacy, 66(6), 518. doi:10.2146/news090023. EBSCO.

"Scientists Develop Genetically Modified Cow That Produces 'human' Breast Milk | Mail Online." Home | Mail Online. Web. 07 Nov. 2011. http://www.dailymail.co.uk/sciencetech/article-1372836/Scientists-develop-genetically-modified-cow-produces-human-breast-milk.html

Pollack, Andrew. "F.D.A. Approves Drug From Gene-Altered Goats - NYTimes.com." NY Times Advertisement. 06 Feb. 2009. Web. 07 Nov. 2011. <http://www.nytimes.com/2009/02/07/business/07goatdrug.html>.

"Genetically Modified Cows Produce Milk Akin To Human Milk | Popular Science." Popular Science | New Technology, Science News, The Future Now. Web. 07 Nov. 2011. <http://www.popsci.com/science/article/2011-04/genetically-modified-cows-produce-milk-human-qualities>.

References:

"FDA OKs Drug from Genetically Altered Animals - Health - Health Care - Msnbc.com." Msnbc.com - Breaking News, Science and Tech News, World News, US News, Local News- Msnbc.com. Web. 07 Nov. 2011. <http://www.msnbc.msn.com/id/29054736/ns/health-health_care/t/fda- oks-drug-genetically-altered-animals/>.

Eeneenam, Alison. "Genetically Engineered Animals: An Overview." Http://agribiotech.info/details/AlisonGE%20Animalssent%20to%20web%2002.pdf. Department of Animal Science University of California, Davis, 22 June 2008. Web. 7 Nov. 2011.

"Bio-10--Pharmaceutical Production from Transgenic Animals." Office of Biotechnology: Iowa State University. Web. 07 Nov. 2011. <http://www.biotech.iastate.edu/biotech_info_series/bio10.html>.

Ritter, Steve. "Erythropoietin." Acs.org. Chemical & Engineering News. Web. 10 Nov. 2011

http://pubs.acs.org/cen/coverstory/83/8325/8325erythropoietin.html

"Genetic Modification." Making the Modern World. Web. 22 Nov. 2011. (no author)<http://www.makingthemodernworld.org.uk/learning_modules/biology>

How the transgenic drugs are useful??? What are the ethical issues in the process of transgenesis???

Question?????

Thank You